Kornimate/medical-research-clean huggingface dataset:
botox injection in treatment of cluster headache

Conditions: Cluster Headache

Summary: cluster headache is an intense and powerful, one-sided headache accompanied by involuntary symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial sweating. the headache is believed to be the most intense of all headaches and among many is totally disabling and of great personal and social consequences. for a small group of patients with episodic and most chronic form, drug therapy has little effect. for them, surgery can be a solution. neuroradiology has found evidence of a possible original activation of cluster headache from the portion of the brain called hypothalamus. furthermore, an activation of the parasympathetic nervous system through the sphenopalatine ganglion, which may also explain some of the one-sided involuntary symptoms, is suspected in cluster headache. injection of botulinum toxin type a (bta) inhibits secretion of synaptic acetylcholine resulting in nerve signals being blocked. the duration of such a blockade is believed to be 3-9 months. the purpose of the present study is to develop and evaluate a new surgical procedure with injection of bta for blocking of the sphenopalatine ganglion. the goal is to relieve the symptoms of refractory cluster headache with a minimal invasive procedure. the main objective of the project is to determine the safety of bta injection in the area of the sphenopalatine ganglion of refractory cluster headache and detect the adverse events. secondary objectives are to identify the changes of headache attacks by the method used.


Eligibility criteria:
inclusion criteria: * informed and written consent * cluster headaches defined in ichd-2 criteria, duration of periods of attacks normally more than 2 months and insufficient effect of available prophylactic treatment exclusion criteria: * heart or lung disease * any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure, related to injection or anesthesia * psychiatric illness that hinders participation in the study * known pregnancy or breast feeding * inadequate use of contraceptives * overuse or abuse of opioids * abuse of medications, narcotics or alcohol * allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type a, botox or any of it's constituents or any other related medication * treatment with medication that can interact with botulinum toxin type a

Keywords: cluster headache botulinum toxin type a sphenopalatine ganglion block autonomic nerve block
conjugated hyperbilirubinemia and pulse oximetry

Conditions: Liver Disease; Hyperbilirubinemia

Summary: the purpose of this study is to determine if higher levels of bilirubin in the blood of people with liver disease affects how accurate a pulse oximeter machine is able to measure the concentration of oxygen in the blood. previous studies have reported conflicting results regarding the affect of high levels of bilirubin in the blood on the accuracy of the pulse oximeter reading. initial studies showed an underestimation of the oxygen concentration in the presence of elevated bilirubin. subsequent studies have suggested that high levels of bilirubin in the blood do not influence the accuracy of the pulse oximeter machine. however, recent reports in bone marrow transplant literature and our personal observations in patients with liver disease suggest that high bilirubin levels are associated with an overestimation of the oxygen concentration as measured by the pulse oximeter machine.


Eligibility criteria:
inclusion criteria: * patients with established liver disease or dysfunction, as determined by abnormal liver function tests, imaging, or biopsy exclusion criteria: * patients with unconjugated hyperbilirubinemia, which could be associated with elevations in carboxyhemoglobin * patients with poor peripheral perfusion that would compromise accurate pulse oximetric determination

Keywords: pulse oximetry blood gas analysis liver disease hyperbilirubinemia
an open single-centre investigation evaluating efficacy in second degree partial thickness burns using a silicone contact layer containing silver.

Conditions: Wound Healing

Summary: approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or the total body surface area (tbsa)and assessed as superficial partial-thickness or superficial deep-partial-thickness. the subject will be assessed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. . the dressing mepilex transfer ag will be used as wound contact layer and gauze rolls and compression as second dressing.

approximately 10 subjects from one site will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent. subjects may have sustained a burn injury covering 1-25% of the total body surface area (tbsa)and assessed as superficial partial-thickness or superficial deep-partial thickness in dept. each subject will be followed one time per week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. healing is defined as ≥95% epithelialisation. percent (%) healed epithelialization will be measured by photo analysing using the pictzar program. dressing changes will be performed at each visit and in between if deemed necessary by the investigator.gauze rolls and compression will be used as secondary dressing.all dressing changes will be registered in a log. pain before, during and after removal will be assessed.

Eligibility criteria:
inclusion criteria: * subject with a second degree (superficial, deep or mixed) partial thickness burn from 1-25% tbsa. * one single, isolated burn area selected for study site study site area should be between 1-15% bsa * male or female * from 18 years and above * either in- or out-patient * thermal burn injury * signed informed consent/assent form exclusion criteria: * electrical, chemical burn etiology * if any full thickness areas are present, these should not be \> 5 % * burn greater than 36 hrs old * burns to face * use of chemical/enzymatic and biological debridement within 7 days of investigation start * presence of inflammation or infection in burn wounds * use of topical antibiotics, antiseptics, or antimicrobials in conjunction with study product. * subjects with lung injury or subject being on a ventilator * subjects with dermatologic skin disorders or necrotizing processes * subjects with insulin dependent diabetes mellitus judged by the investigator to be a potential interference in the treatment * diagnosed underlying disease(s) (e.g hiv/aids, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment * subject not expected to follow the investigation procedures * subjects previously included in this investigation * subjects included in other ongoing clinical investigation at present or during the past 30 days
paclitaxel plus raltitrexed plug compare with taxol second-line treatment for advanced gastric cancer

Conditions: Advanced Gastric Cancer

Summary: the purpose of this study is to evaluate and compare safety and effectiveness of chemotherapy in paclitaxel plus raltitrexed plug compare with taxol second-line treatment for advanced gastric cancer

from the first cycle of treatment (day one) to two month after the last cycle

Eligibility criteria:
inclusion criteria: 1.18\~75 years old 2.pathological diagnosis of gastric cancer or gastroesophageal junction adenocarcinoma 3.patient failed after the first line treatment of 5-fu and platinum ,patient relapse half year after using 5 - fu and platinum as postoperative adjuvant chemotherapy 4.ecog 0-1 5.at least one measurable objective tumor lesions 6.anc≥1.5\*109/l；plt≥80\*109/l；hb≥90g/l；tbi≤1.5(unl); alt、ast≤1.5uln； cr≤uln；ccr≥60ml/min 7.expected survival period for 3 months or more 8. patients with voluntary participation, and sign the informed consent exclusion criteria: 1. recurrence after transfer have received taxol or docetaxel as first-line chemotherapy,if the adjuvant chemotherapy with paclitaxel,from the last chemotherapy for 6 months or less 2. with uncontrollable large pleural or peritoneal effusion 3. in the near future has a history of myocardial infarction (3 months) 4. malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas; 5. with brain metastasis 6. severe uncontrolled medical disease or acute infection 7. pregnancy or breast-feeding women 8. has a long history of chronic diarrhea, or now complete intestinal obstruction patients

Keywords: pfs
impact of crutch type on gait and functional outcomes post-knee surgery

Conditions: Total Knee Arthroplasty; Anterior Cruciate Ligament Reconstruction

Summary: study withdrawn

study withdrawn

Eligibility criteria:
inclusion criteria: * subjects 45-75 years old planning to get their first total knee replacement * subjects 18-45 years old planning to get their first anterior cruciate ligament reconstruction exclusion criteria: * previous injury to shoulder, elbow, or wrist * current pain in shoulder, elbow, or wrist * inflammatory arthritis (i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), * history of cerebral palsy, stroke, significant cognitive impairment, or significant visual impairment * problems with the heart or lungs * currently using a crutch or crutches, walker, or other gait aid * history of using a crutch or crutches for 4 or more weeks * inability to communicate in english * current smoker * currently pregnant

Keywords: crutches gait mobility adult knee replacement acl tear
regulation of lipoprotein transport in metabolic syndrome

Conditions: Obesity; Lipid Disorders; Cardiovascular Disease

Summary: the purpose of this study is to determine whether ppar-delta agonist (gw5015156)had favorable effect on lipoprotein metabolism.

the metabolic syndrome (mets) portends diabetes and cardiovascular disease (cvd). dyslipoproteinaemia, reflected by elevated plasma triglyceride and reduced high-density lipoprotein (hdl) concentrations, is a cardinal feature of mets that independently predicts cvd and is accordingly a therapeutic target for risk reduction. gw5015156 is a new ppar-delta agonist that could be used to treat dyslipidemia in insulin resistance and obesity. however, the precise mechanisms of action of this agent on lipoprotein kinetics in mets subjects have not yet fully been investigated. we therefore carried out a study to study the effect of gw5015156 on lipoprotein transport in subject with metabolic syndrome.

Eligibility criteria:
inclusion criteria: * any three of the following: * waist circumference \> 102 cm * triglycerides \> 150 mg/dl * hdl-cholesterol \< 40 mg/dl * blood glucose \> 110 mhg/dl * blood pressures \> 130/85 mmhg exclusion criteria: * triglycerides \> 500 mg/dl * diabetes mellitus * cvd * consumption of \> 30 g alcohol/day * use of agents affecting lipid metabolism * apoe2/e2 genotype * creatinemia (\> 120 umol/l) * hypothyroidism * abnormal liver and muscle enzymes

Keywords: drug treatment
dural puncture epidural technique for vaginal procedures

Conditions: Gynecologic Diseases Requiring Vaginal Hysterectomy

Summary: 25g dural puncture epidural technique will be compared with conventional standard lumbar epidural technique during anesthesia of laparoscopic assisted vaginal hysterectomy.


Eligibility criteria:
inclusion criteria: * age: 25-55 years old. * height: 165 cm. exclusion criteria: * patient refusal. * coagulopathy. * deformity of lumbar vertebrae.
the effect of continued mechanical ventilation on the occurrence of myocardial ischemia

Conditions: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Hypoxia

Summary: the goal of this study is to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-cabg.

coronary artery bypass grafting (cabg) surgery is one of the main treatment options for patients suffering from coronary artery disease, a condition characterized by a build-up of cholesterol in the coronary arteries of the heart that affects 126 million people worldwide each year. during this procedure, cardiopulmonary bypass (cpb) takes over the function of the heart and lungs. in recent years, there has been a huge focus on reducing surgical trauma in this procedure, leading to the emergence of minimally invasive cardiac surgery (mics) such as endoscopic cabg (endo-cabg). in these techniques, peripheral cpb with femoral arterial cannulation is the most commonly used strategy. however, the use of retrograde arterial perfusion is not without risk. it can cause that the upper part of the body only receives deoxygenated blood. the effect on the heart is not yet fully known. the hypoxemia could cause myocardial ischemia and this could damage the heart muscle cells. it is reported in the literature that establishing adequate ventilation from the initiation of cpb to cardiac arrest can resolve this phenomenon. this approach was investigated in a recently performed double-blinded, randomized, controlled pilot study (n=10) of our research group. however, a larger randomized controlled trial was needed. therefore, this research aims to investigate the effect of continued mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-cabg.

Eligibility criteria:
inclusion criteria: * patients older than 18 years old * patients undergoing their first elective endo-cabg procedure using peripheral cannulation for cpb * patients who are able to give their informed consent * patients who speak dutch or french exclusion criteria: * patients participating in another clinical trial * patients taking corticosteroids * patients with an ejection fraction \< 25% * patients with lung diseases (chronic obstructive pulmonary disease (copd), asthma) * patients where groin cannulation is not possible

Keywords: cardiac surgery minimally invasive cardiac surgery endoscopic coronary artery bypass grafting harlequin syndrome ventilation
a drug-drug interaction study of s-892216 coadministered with carbamazepime to healthy adult participants

Conditions: COVID-19

Summary: the primary objective of this study is to investigate the effect of multiple-dose administration of carbamazepine on the pharmacokinetics of s-892216 in healthy adults.


Eligibility criteria:
key inclusion criteria: * overtly healthy as determined by medical evaluation including medical history, medical examination, laboratory tests, vital sign measurements, and 12-lead electrocardiogram, at screening and on admission or participants whose laboratory values exceed the institutional reference range but deemed not clinically significant by the investigator in consideration of safety. * body mass index ≥18.5 and ≤32.0 kilograms/meter squared. exclusion criteria: * this study will not enroll participants with asian ancestry, defined as individuals who have 1 or more asian grandparent, due to significant increase of risk for carbamazepine-related serious dermatologic reactions almost exclusively in these populations. * presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (that is, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment. * history of adverse hematologic reaction to any drug, or a history of bone marrow depression. * history or family history of severe cutaneous reactions including toxic epidermal necrolysis and stevens-johnson syndrome. * prior carbamazepine use that was discontinued for tolerability or adverse events, including a clinically significant decrease in platelets, white blood cells, or hemoglobin. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: s-892216 carbamazepine covid-19
feasibility trial of the dc devices interatrial septal device (iasd) system

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate the safety and potential benefits of the interatrial septal defect (iasd) system in patients with heart failure with preserved ejection fraction.

the study was a multi-center, non-randomized feasibility evaluation of the iasd system at three centers in three countries (denmark, australia, and czech republic). relevant ethics committee and competent authority approvals were obtained. the study was conducted in accordance with the declaration of helsinki. the protocol required the treatment of a minimum of 5 patients, and allowed up to twenty patients to be enrolled. the primary objective of the trial was to evaluate the safety and potential benefits of the iasd device system in the treatment of patients with symptomatic heart failure with preserved ejection fraction, despite optimal medical management.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hfpef * ejection fraction of at least 45% * imaging and hemodynamic evidence of hfpef * history of exercise intolerance * symptomatic despite optimal medical management * signed study specific informed consent exclusion criteria: * history of thromboembolic events * significant structural heart disease or coronary artery disease * contraindicated to study required medication * right ventricular dysfunction * history of greater than mild restrictive or obstructive lung disease * life expectancy less than one year for non-cardiovascular reasons * known or suspected allergy to implant material * fertile women
the retention rate between brand a and brand b punctal plugs

Conditions: Dry Eye

Summary: the purpose of this study is to determine if parasol punctal occluders (brand a) have a higher rate of retention than superflex punctal plugs (brand b).

eyes will be randomized to either brand a or brand b punctal plug. the primary outcome measure is length of time punctual plugs are retained, measured in months. this will be measured at monthly assessments for 6 months. secondary outcome measures include patient satisfaction, and improvement in subjective and objective dry eye scores, as well as complications related to punctual plugs including spontaneous plug loss, and intolerance. we will evaluate these measures by repeating the canadian dry eye assessment, schirmer 1, tear meniscus height, fluorescein corneal staining (nei scale), and lissamine green conjunctival staining (nei scale) at month 1, month 3, and month 6 visits.

Eligibility criteria:
inclusion criteria: * moderate dry eye, severe dry eye exclusion criteria: * silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
low level laser therapy and rocabado's approach for myogenic tmj disorders

Conditions: Myogenic Temporomandibular Joint Disorders

Summary: rocabado's 6x6 exercises are designed to improve muscular co-ordination, relax tense muscles, increase temporomandibular joint (tmj) rom, alter the jaw closure pattern and muscle strength. these exercises have been found to be beneficial in reducing pain and increasing masticatory muscle function, as well as restoring restricted joint mobility, muscle length limitation, and postural and functional limitations. in addition, low level laser therapy (lllt) has been reported to reduce inflammation and pain in patients with tmj dysfunction. although that to the best of the authors' knowledge the combined effect of rocabado's approach with lllt has not been studied. so, the current study is the first double-blind placebo-controlled clinical trial that investigating the effect of adding lllt to rocabado's approach for tmj myogenic disorders.


Eligibility criteria:
inclusion criteria: (1) the patient's ages ranged from 18 to 40 years ; (2) having symptoms of tmd for at least twelve weeks duration established by expert physician or orthopaedician; (3) mouth opening \< 25mm exclusion criteria: (1) tmj fracture undergone any surgical procedure for tmj; (2) fracture surrounding tmj; (3) dislocation or subluxation of tmj; (4) systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases or facial paralysis; (5) recently any dental treatment taken or surgery over tmj; (6) hematological cervical disorders which may affect the jaw; (7) neurological deficits e.g. bells palsy, trigeminal neuralgia; (8) recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection; (9) participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study.
high-flow nasal cannula (hfnc) preoxygenation in obese patients undergoing general anesthesia

Conditions: Preoxygenation; Anesthesia; Obesity

Summary: this study aims to evaluate the effectiveness of the high flow nasal cannula (hfnc) for the preoxygenation of obese patients undergoing a general anesthesia. the hfnc interface is compared to a standard anesthesia facemask (fm) preoxygenation with continuous positive airway pressure (cpap), the current gold standard procedure for obese induction. the interest of hfnc preoxygenation is to increase the "safe apnea time" before critical arterial desaturation, useful in the management of difficult airways, especially in subjects with reduced respiratory reserves such as the obese.


Eligibility criteria:
inclusion criteria: * surgery with the need for general anesthesia with muscle relaxation * asa (american society of anesthesiologists) physical status score ii-iii * bmi \> 35 exclusion criteria: * severe respiratory disease (acute respiratory failure, chronic obstructive pulmonary disease copd, parenchymal pneumopathies,...) * severe nasal pathology (malformation, stenosis) * criteria or previous difficult intubation * bmi \> 50 * chest circumference \> 150cm * implanted electronic device (pacemaker, neurostimulator, ...) * pregnancy